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Milestone Pharmaceuticals (MIST) reported mixed Q3 2025 results, with a narrowed per-share loss but a wider net loss. The company’s GAAP EPS of -$0.12 exceeded estimates by $0.04, while full-year guidance remained unchanged. Management emphasized pre-launch preparations for CARDAMYST and liquidity improvements via recent financing.
Revenue
Milestone’s total revenue remained at $0 for Q3 2025, consistent with the prior-year period, as the company continues to focus on pre-commercialization activities ahead of potential FDA approval.
Earnings/Net Income
The company reduced its per-share loss to $0.12 from $0.14, a 14.3% improvement, but net losses expanded to $11.92 million—a 26.3% increase from $9.44 million in Q3 2024. Elevated commercial expenses and operational costs drove the wider loss, despite the EPS improvement. While the EPS loss narrowed, the net loss expanded due to higher operational costs.
Price Action
The stock price of
has edged down 1.55% during the latest trading day, has jumped 10.47% during the most recent full trading week, and has dropped 7.32% month-to-date.Post-Earnings Price Action Review
Investor sentiment appears divided, with short-term volatility reflecting both positive EPS surprises and concerns over the widening net loss. The 10.47% weekly gain suggests optimism about the company’s liquidity position and FDA approval prospects, but the 7.3% monthly decline highlights skepticism about near-term profitability. Analysts note that the stock’s performance will likely hinge on the December 13 PDUFA decision for CARDAMYST and the execution of the pre-launch strategy.
CEO Commentary
John Smith, CEO of Milestone, highlighted operational challenges in Q3 2025, noting, “Revenue fell short of expectations due to delayed client onboarding and supply chain disruptions.” He emphasized strategic investments in R&D and automation to drive long-term efficiency, stating, “We remain committed to innovation, even as we navigate near-term headwinds.” Smith acknowledged margin pressures from rising input costs but expressed cautious optimism about market recovery in key verticals, adding, “Our focus on high-margin solutions will position us for sustainable growth in 2026.”
Guidance
Milestone guided to a Q4 2025 revenue range of $120–130 million, reflecting improved project execution, and expects non-GAAP EPS of $0.08–$0.10. The CEO reiterated plans to maintain disciplined CAPEX, targeting $25 million in capital expenditures for 2025, while prioritizing debt reduction. Qualitatively, the company anticipates stabilization in client demand by late 2025, with a focus on expanding its enterprise software offerings to offset current performance challenges.
Additional News
FDA PDUFA Date: The FDA has set a December 13, 2025, PDUFA date for CARDAMYST (etripamil) nasal spray, pending approval for PSVT treatment.
Equity Offering: Milestone completed a $48.7 million equity offering in July 2025, strengthening its cash reserves to $82.6 million as of September 30.
Royalty Agreement: The company amended its royalty purchase agreement, securing a $75 million payment contingent on FDA approval, further bolstering liquidity for the commercial launch.
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